Kornimate/medical-research-clean huggingface dataset:
prospective observational analysis of cr with sunitinib treatment in mrcc patients

Conditions: Complete Remission in Renal Cell Carcinoma

Summary: this prospective study will investigate the characteristics of mrcc patients at time of cr in comparison with mrcc patients non on cr treated with sunitinib, in order to provide some answers/ refection leads to the following questions : can we identify blood specificity at time of cr vs non on cr? shall we distinguish cr with sunitinib alone from combined cr (sunitinib with local treatment), while in clinical report these 2 cohorts present similar time to recurrence (albiges, asco 2010)? can we identify potential predictive serum biomarkers of recurrence? (with the aim of isolating blood biomarker that can help on treatment discontinuation decision?)

the main objective of the study is to describe the characteristics of mrcc patients on cr with sunitinib (cases) and compare them to the characteristics of mrcc patients non on cr (controls) in order to identify factors associated with the occurrence of complete remission. the results obtained on the sample must be representative of the population targeted by the study. the most appropriate method to obtain a representative sample is probability sampling. a sample size of n = 40 (cases) and n = 80 (controls) will provide a power of 80% in the detection of a frequency difference between cases and controls corresponding to an or of 0.24 for a parameter frequency 10% in control arm and an or of 0.30 for a parameter frequency of around 30% in control arm. the significance level was set at bilateral 5%. the data will be analyzed using sas software (version 9.1 - sas institute, north carolina, united states).

Eligibility criteria:
inclusion criteria: * patients with metastatic renal cell carcinoma, histopathologically confirmed * treated with sunitinib according to smpc * for cases: achieving a cr (local assessment according to recist v1.0 criteria) with sunitinib in prior 6 months alone or in combination with local treatment (surgery, radiation therapy, ablative techniques: cryotherapy, rfa) * for controls: life expectancy \> 3 months no prior sunitinib treatment * patient \>18 years exclusion criteria: * sunitinib administered in a non-approved label * for cases: cr occurring without sunitinib treatment * for controls: prior systemic treatment

Keywords: complete remission
efficacy and safety study of prolonged-release fampridine in participants with multiple sclerosis

Conditions: Multiple Sclerosis

Summary: the primary objective is to determine whether prolonged-release fampridine (10 mg twice daily) has a clinically meaningful effect on participant-reported walking ability over a 24-week study period. the secondary objectives are: to determine whether prolonged-release fampridine 10 mg taken twice daily (bid) has a clinically meaningful effect on dynamic and static balance, physical impact of multiple sclerosis (ms), and upper extremity function over a 24-week study period; to evaluate criteria for early assessment of response to fampridine that can predict clinically meaningful benefits in walking ability and balance; to assess the safety and tolerability of prolonged-release fampridine 10 mg twice daily over a 24-week treatment period.


Eligibility criteria:
key inclusion criteria: * must have a diagnosis of primary-progressive, secondary-progressive, progressive-relapsing, or relapsing-remitting ms per revised mcdonald committee criteria \[mcdonald 2001; polman 2005\] as defined by lublin and reingold \[lublin and reingold 1996\] of at least 3 months duration * must have an expanded disability status scale (edss) score of 4 to 7, inclusive * must have walking impairment, as deemed by the investigator key exclusion criteria: * history of human immunodeficiency virus (hiv) * presence of acute or chronic hepatitis. subjects who have evidence of prior hepatitis infection that has been serologically confirmed as resolved are not excluded from study participation * known allergy to fampridine, pyridine-containing substances, or any of the inactive ingredients in the prolonged-release fampridine tablet * creatinine clearance (crcl) of \<80 ml/min * history of malignant disease * presence of pulmonary disease * a body mass index (bmi) ≥40 (bmi formula: bmi = mass \[kg\]/\[height(m)\]2) note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: fampridine
dose-ranging trial of safety & immunogenicity of an oral adenoviral-vector based rsv vaccine (vxa-rsv-f)

Conditions: Respiratory Syncytial Virus (RSV)

Summary: a phase 1, randomized, double-blind, placebo-controlled, dose-ranging trial to determine the safety and immunogenicity of an adenoviral-vector based respiratory syncytial virus (rsv) f protein vaccine (vxa-rsv-f) expressing protein f and dsrna adjuvant administered orally to healthy volunteers

the study will enroll 66 subjects in four cohorts. all subjects will receive a single administration of vxa-rsv-f at a low dose, a high dose or placebo. two sentinel groups will enroll 3 subjects each in an open-label manner (cohorts 1 and 3) to receive vxa-rsv-f prior to enrolling either of the randomized, controlled cohorts (cohorts 2 and 4). within the double-blinded cohorts (2 and 4), placebo subjects will receive the same number of tablets as the vaccine subjects in that cohort. subjects will be enrolled and dosed in the low dose groups prior to initiation of dosing in the high dose group. cohort 1: 3 subjects at low dose cohort 2: 20 subjects at low dose and 10 placebo cohort 3: 3 subjects at high dose cohort 4: 20 subjects at low dose and 10 placebo subjects will be followed for 28 days post vaccination for preliminary immunogenicity. subjects will continue to be followed for 1 year post-vaccination for long term safety.

Eligibility criteria:
inclusion criteria: 1. male or female volunteers aged 18 - 49 years, inclusive 2. able to give written informed consent 3. healthy (no clinically significant health concerns) 4. safety laboratory values within the following range criteria normal range 5. body mass index between 17 and 35 at screening exclusion criteria: 1. receipt of any investigational rsv vaccine within two years prior to study 2. receipt of any investigational vaccine, drug or device within 8 weeks preceding vaccination 3. administration of any licensed vaccine within 30 days prior to study 4. presence of significant uncontrolled medical or psychiatric illness (acute or chronic) including institution of new medical/surgical treatment or significant dose alteration for uncontrolled symptoms or drug toxicity within 3 months of screening and reconfirmed at baseline 5. history of drug, alcohol or chemical abuse within 1 year prior to vaccination 6. presence of a fever ≥ 38oc measured orally at baseline 7. stool sample with occult blood at screening
evaluation of nelfinavir and chemoradiation for pancreatic cancer

Conditions: Pancreatic Neoplasms

Summary: this study is designed to evaluate if nelfinavir works as a radiation sensitizer in combination with gemcitabine (a chemotherapy). we are also looking to establish the maximum dose of gemcitabine that is tolerated with the nelfinavir and radiation therapy, so the dose of gemcitabine is increased based on how previous trial participants tolerated their dose of gemcitabine.

this trial utilizes gemcitabine (a chemotherapy agent commonly used for pancreatic cancer) and nelfinavir (an anti-retroviral agent fda-approved for use in hiv+ patients) in addition to radiation therapy for treatment of borderline resectable pancreatic cancer. the trial seeks to determine the maximum tolerated dose of gemcitabine when administered concurrently with radiation therapy and 1250 mg nelfinavir twice daily. the gemcitabine and radiation is standard; the dose of gemcitabine does vary nationally and internationally as to what the 'best dose' is. administered weekly, doses can range from 400 mg/m2 to 1000 mg/m2. thus, this is why the proposed clinical trial escalates the gemcitabine. the gemcitabine will be administered weekly during radiation therapy for a total of 6 cycles. after completion of radiation therapy, the subjects will be evaluated by the surgeons for resectability. this ends the active portion of the clinical trial; the subjects will be followed for long-term progression free survival and for overall survival. primary endpoints for this trial are identifying the maximum tolerated dose of gemcitabine when administered concurrently with nelfinavir and radiation therapy (the phase i portion of this study) and the rate of resectability (typically, utilizing gemcitabine plus radiation therapy will convert up to 30% of patients from borderline resectable to resectable) for the phase ii portion of the study. interim analyses and stopping rules are in place if an effect size is not observed in the therapeutic group compared to published reports of response to standard chemoradiation for borderline resectable cases.

Eligibility criteria:
closed to accrual.

Keywords: radiotherapy gemcitabine nelfinavir neoplasms
retrospectively analyze the risk factors of vte in 5774 patients with thoracic trauma from 33 hospitals in china, and established a risk prediction model

Conditions: Thorax Injuries; Embolism Vein; Embolism, Pulmonary; Rib Fractures

Summary: retrospectively analyze the risk factors of vte in 5774 patients with thoracic trauma from 33 hospitals in china, and established a risk prediction model

in order to explore the risk factors of vte after acute thoracic trauma, we collected the diagnosis and treatment information of 5774 patients with thoracic trauma from 33 hospitals in china, retrospectively analyzed the risk factors of vte in patients with thoracic trauma, and established a risk prediction model.

Eligibility criteria:
inclusion criteria: * admitted within three days of the chest trauma, vte has not yet occurred, ais score of thoracic injury was greater than or equal to 3, ais score of other combined injuries was less than or equal to 2. exclusion criteria: * received preventive physical or chemical anticoagulation before admission, vte occurred before admission

Keywords: venous thrombus embolism thorax injuries risk factors prediction model
effects of carotid stent design on cerebral embolization

Conditions: Stroke; Carotid Stenosis

Summary: the goal of the proposed study is to contrast the relative efficacy of closed-cell stents versus open-cell stents in preventing periprocedural cerebral embolization in high-risk patients with symptomatic and asymptomatic extracranial carotid stenosis undergoing carotid artery stenting (cas).

stroke is responsible for more than 10% of all deaths and much severe disability in developed countries. in the united states, approximately 600,000 new strokes are reported annually, of which 150,000 are fatal, and more than 4,000,000 surviving stroke victims are affected by significant disability. seventy-five percent of strokes occur in the distribution of the carotid arteries and are considered of a thromboembolic etiology, most of which originate in carotid lesions. carotid artery stenting (cas) with cerebral embolic protection is currently the preferred treatment of carotid stenosis in high risk surgical patients, i.e., those with significant comorbidities or a hostile neck from previous surgical procedures or radiation. although several predictors of adverse outcomes after cas have been identified, the effects of device characteristics, including stent design, on neurologic adverse events have not been established. the proposed study will be a randomized prospective controlled trial designed to test the hypothesis that the implantation of closed-cell stents for carotid lesions in high-risk patients will be associated with a reduced perioperative cerebral microembolization, as detected by transcranial doppler and diffusion-weighted magnetic resonance imaging of the brain, and reduced 30-day stroke, myocardial infarction, and death rates when compared with the implantation of open-cell stents.

Eligibility criteria:
inclusion criteria: * subject is at high risk for carotid endarterectomy due to either anatomic or co-morbid conditions; and * symptomatic patients (tia or non-disabling stroke within 6 months of the procedure), with carotid stenosis ≥ 50% as diagnosed by angiography, using nascet methodology (50); or * asymptomatic patients with carotid stenosis ≥ 80% as diagnosed by angiography, using nascet methodology exclusion criteria: * conditions that interfere with the evaluation of endpoints * subject has anticipated or potential sources of cardiac emboli * subject plans to have a major surgical procedure within 30 days after the index procedure. * subject has intracranial pathology that makes the subject inappropriate for study participation. * subject has a total occlusion of the ipsilateral carotid artery (i.e., cca). * severe circumferential lesion calcification that may restrict the full deployment of the carotid stent. * carotid stenosis located distal to the target stenosis that is more severe than the target stenosis.

Keywords: stroke carotid stenosis stents
evaluation of the inflammation-based index as a predictive marker of clinical and radiological response in patients treated with lu-177 oxodotreotide for intestinal neuroendocrine tumour

Conditions: Intestinal Neuroendocrine Tumor

Summary: this is a prospective, multicenter, open-label study designed to evaluate the specificity and sensitivity of the inflammation based index (ibi) score as a marker for predicting clinical and radiological response in patients treated with lu-177 oxodotreotide for inoperable or metastatic, progressive, grade 1 or 2 intestinal neuroendocrine tumors. this ibi score will be assessed on the basis of c-reactive protein (crp) and albumin values, and will be defined as follows: * ibi = 0: low mortality risk (if crp and serum albumin values are considered normal in the investigator's judgment). * ibi \> 0, including: ibi = 1: intermediate risk of mortality (if one of the two values is considered abnormal and clinically significant according to the investigator's judgment (either hypoalbuminemia or elevated crp)); ibi = 2: high mortality risk (if both values are considered abnormal and clinically significant according to the investigator's judgment (hypoalbuminemia and elevated crp)). patients were followed up for 36 months. a total of 150 patients should be included in this study.


Eligibility criteria:
inclusion criteria: 1. patient aged ≥ 18 years. 2. patient with histologically confirmed grade 1 or 2 neuroendocrine tumor of the midgut, inoperable or metastatic. 3. patient eligible for lu-177 oxodotreotide therapy in accordance with its marketing authorization. 4. evidence of progression in the 12 months preceding lu-177oxodotreotide therapy, confirmed by imaging techniques commonly used in current practice (thoraco-abdomino-pelvic ct and/or liver mri, ga-68 dota somatostatin analog pet-ct) +/- liver involvement greater than 50%. 5. disease measurable according to recist 1.1 criteria in thoraco-abdomino-pelvic ct +/- liver mri. 6. patient affiliated to a social security scheme in france. 7. patient having signed informed consent prior to study inclusion and prior to any specific study procedure. exclusion criteria: 1. previous treatment with lu-177 oxodotreotide. 2. any contraindication to treatment with lu-177 oxodotreotide. 3. morbid obesity (bmi \> 40). 4. uncontrolled/unbalanced active inflammatory disease in the 3 months prior to inclusion. 5. active carcinoid heart disease or other acute cardiovascular event. 6. active infection not treated within 15 days. 7. pregnant or breast-feeding woman. 8. any psychological, family, geographical or sociological condition that prevents compliance with the medical follow-up and/or procedures stipulated in the study protocol. 9. patient deprived of liberty or under legal protection (guardianship, legal protection).

Keywords: intestinal neuroendocrine tumor lu-177 oxodotreotide ibi score biomarker
a worldwide, phase i, dose-escalating study of a 3-dose regimen of the mrkad5 (clade b) vaccine in healthy adults (v520-018)

Conditions: HIV-1; HIV Infections

Summary: this three stage study will evaluate the safety and tolerability of mrkad5 hiv-1 gag vaccine. in stage i subjects will be randomized to receive the vaccine at 1x10\^9 viral particles/dose (vp/d) or placebo. in stage ii subjects will be randomized to receive the vaccine at 1x10\^10 vp/d or placebo. in stage iii subjects will be randomized to receive the vaccine at 1x10\^9 vp/d, at 1x10\^10 vp/d, or placebo. immunogenicity of the single dose regimen of mrkad5 hiv-1 gag vaccine will also be measured.


Eligibility criteria:
inclusion criteria: * subject is in good general health * subject tests negative for hepatitis b, hepatitis c, and hiv * subjects of reproductive potential agree to use an accepted method of birth control through the entire study exclusion criteria: * subject has a recent history of fever at time of vaccination * subject has received immune globulin or blood product 3 months prior to injection * subject has been vaccinated with live virus vaccine 30 days prior to receipt of first dose * subject has been vaccinated with inactivated vaccine with 14 days prior to receipt of first dose * subject has a chronic medical condition that is considered progressive * subject has history of malignancy * subject weighs less than 105 lb. * female subject is pregnant or breast feeding, male subject is planning to impregnate during the first year of study * subject has contraindication to intramuscular injection * subject is unlikely or unwilling to adhere to lower risk sex practices during the course of the study * subject has a tattoo on the deltoid region of the arm or the injection of depo-provera

Keywords: hiv seronegativity preventive vaccine
the potential effects of inofolic plus on abnormal ovarian reserve parameters in subfertile women

Conditions: Infertility, Female

Summary: dr. roseff and his colleagues are conducting a study to evaluate the effectiveness of a novel substance (inofolic plus®) in improving oocyte (egg) parameters in subfertile female patients, as measured through anti-mullerian hormone (amh) blood levels.

inofolic plus® contains several nutritional elements including myo-inositol, melatonin, and folic acid. myo-inositol was found to be helpful in improving egg quality and/or quantity in women with an ovarian abnormality called polycystic ovarian syndrome as well as in women without the disorder undergoing assisted reproduction. myo-inositol and folic acid are compounds that belong to the family of b-vitamins. inositol is normally found in several types of foods. folic acid has been found to significantly decrease the incidence of certain types of birth defects in women taking sufficient amounts prior to and during pregnancy. preliminary studies using myo-inositol and folic acid demonstrated improvement in egg quality in-vitro and in-vivo as well as multiple metabolic parameters in women with irregular menstrual cycles and certain types of hormone imbalances. melatonin is a potent antioxidant. folic acid is not classified as an antioxidant but has been reported to have antioxidant-like activity. antioxidants have been given to infertile men for years to improve egg parameters. most recently, studies have documented the efficacy of antioxidant treatment on human egg parameters and fertilization rates, especially in the setting of in-vitro fertilization (ivf). inofolic plus® contains melatonin and folic acid. dr. roseff hypothesizes that inofolic plus® may be effective in correcting abnormal egg parameters in women. a woman may have abnormal eggs from being exposed to environmental and workplace toxins that generate oxygen free radicals in her body (known as reactive oxygen species, or ros). these ros circulate through the blood stream and can enter the ovaries where eggs are stored. eggs may be sensitive to ros, and damage from the ros may result in poor egg quality or quantity or both. the combination of nutrients and antioxidants in inofolic plus® may help to correct these abnormalities. melatonin is a natural hormone normally found in the brain. this hormone helps regulate sleep/wake cycles. melatonin levels increase during the evening and remain high during the night. this elevated level of melatonin is thought to induce drowsiness. it is because of this effect that we recommend taking inofolic plus® in the late evening near bedtime.

Eligibility criteria:
inclusion criteria: * female between 18 - 42 years of age * diagnosed with "diminished ovarian reserve" (dor) exclusion criteria: * ongoing history of illicit drug or tobacco use * ovarian surgery within 90 days of signing the consent form

Keywords: female fertility ovarian reserve oocyte quality oocyte quantity antimullerian hormone amh dietary supplements inofolic plus myoinositol folic acid
web-based training for eap alcohol screening, brief intervention, and refer

Conditions: Alcohol Consumption; Alcohol Abuse

Summary: the goal of the proposed research is to complete the development of a web-based program to train employee assistance program (eap) and eap-affiliated managed behavioral health organization (mbho) practitioners to conduct screening, brief intervention, and referral to treatment (sbirt) for problem alcohol use among working adults.

in phase 2, the investigators propose to develop the sbirt training \& support tool with two components: (1) online sbirt training for call-center and face-to-face practitioners conducting alcohol sbirt and (2) sbirt support tool with mobile/web interactive alcohol screening tools and brief intervention protocols to facilitate use of sbirt by practitioners. the sbirt training component will provide practitioners with the skills, knowledge, motivation, and self-efficacy to: (a) screen their clients for unhealthy alcohol use with validated screening tools; (b) provide brief, motivational interviewing-informed intervention; and (c) make appropriate referrals. the training program will incorporate the phase 1 content and expand the curriculum to include the use of additional validated alcohol screening tools. content for alcohol sbirt will be derived from niaaa evidence-based materials. the sbirt support tool will provide a mobile/web interface for practitioners to use interactive screening and brief intervention forms with (a) prompts for validated questions in the screening or brief intervention; (b) motivational interviewing-informed dialogue suggestions; (c) online resources (i.e., standard drink list; importance, confidence rulers); and (d) alcohol education and referral information. the practitioner will use the sbirt support tool to (a) screen clients for alcohol use with interactive validated screening tools; (b) provide brief intervention for individuals based on their screening score; and (c) provide referral to treatment for individuals based on their screening score.

Eligibility criteria:
inclusion criteria: * eap/bh practitioners will be employed at an eap or behavioral health organization * have an e-mail account * access to high-speed internet connection * speak and read english exclusion criteria: * younger than 18 * not an eap practitioner * no access to e-mail * no access to the internet * do not speak and read english